FDA 510(k)

TSV BellaTek 編碼治療基座

K 號：K173374 · 2017-12-13

決定日期2017-12-13

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

TSV BellaTek Encode Healing Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K173374. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TSV BellaTek Encode Healing Abutments?

TSV BellaTek Encode Healing Abutments is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Biomet 3i. The 510(k) number is K173374.

When did TSV BellaTek Encode Healing Abutments receive FDA 510(k) clearance?

TSV BellaTek Encode Healing Abutments received FDA 510(k) clearance on 2017-12-13, under 510(k) number K173374.

Who is the listed applicant for TSV BellaTek Encode Healing Abutments?

The FDA 510(k) record lists Biomet 3i as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSV BellaTek Encode Healing Abutments?

The FDA product code for TSV BellaTek Encode Healing Abutments is NHA.

其他以 Biomet 3i 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：NHA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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